NCT00747097
Completed
Phase 2
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country43 target enrollmentSeptember 2008
Overview
- Phase
- Phase 2
- Intervention
- gemcitabine + cetuximab
- Conditions
- Time to Progression
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
- •signed written informed consent
- •age \> 18
- •WHO PS 0 or 1 at study entry
- •measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
- •adequate renal (serum creatinin\<1.5x upper reference range), liver (total bilirubin\<2x upper reference range) and hematopoietic functions (PMN\>1,5x109/L, platelets\>100x109/L)
- •life expectancy of at least 12 weeks
- •effective contraception throughout the study for both male and female patients if the risk of conception exists
Exclusion Criteria
- •uncontrolled concurrent CNS, cardiac, infectious diseases
- •previous exposure to epidermal growth factor targeting therapy
- •known hypersensitivity to any components of study treatments
- •previous chemotherapy for this cancer
- •previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- •pregnancy or breast feeding
- •medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
Arms & Interventions
1
gemcitabine+cetuximab
Intervention: gemcitabine + cetuximab
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 6 months
Secondary Outcomes
- overall survival, objective response, safety(12 months)
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 2
Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder CancerBladder CancerNCT01916109Memorial Sloan Kettering Cancer Center4
Completed
Phase 2
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder CancerBladder CancerUrinary BladderNCT00847015Memorial Sloan Kettering Cancer Center18
Terminated
Phase 2
Phase II Study of Gemcitabine and TS-1 in Biliary Trat CancerBiliary Tract CancerNCT01171755Samsung Medical Center19
Completed
Phase 2
Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic CancerPancreatic CancerNCT00696696NYU Langone Health45
Recruiting
Phase 2
Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic CholangiocarcinomaIntrahepatic CholangiocarcinomaNCT06298968Nanfang Hospital, Southern Medical University38